Navigation Links
Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium Difficile
Date:11/19/2012

TURKU, Finland, November 19, 2012 /PRNewswire/ --

Abacus Diagnostica Ltd announced that it has received the CE mark for the GenomEraC. difficile assay for the detection of toxin-producing Clostridium difficile directly from stool samples. C. difficile is the leading cause of infectious nosocomial diarrhea in Europe and North America.

     (Photo: http://photos.prnewswire.com/prnh/20121119/574465 )

Rapid changes in the epidemiology and increasing incidence have taken the focus on methods to diagnose toxigenic  C. difficile faster and more efficiently. Accurate and rapid diagnosis of C. difficile infection is crucial for patient care but also for preventing transmission and reducing the overall disease burden.

The GenomEra C. difficile assay is the newest test of Abacus Diagnostica's expanding line of easy-to-use and cost-efficient molecular diagnostics products. The C. difficile test is extremely simple to perform directly from stool specimen through a straightforward sample preparation process without extraction, heating or centrifugation steps. The assay is built on rapid and reliable target amplification and end-point detection technology that allows for high quality results in 50 minutes.

"Abacus is committed to providing a continuum of diagnostic products for key infectious diseases to meet the needs of various laboratory settings," said Tom Palenius, CEO of Abacus Diagnostica. "Along with our earlier CE marked MRSA/SA assays this PCR test will help to meet the testing and resource challenges of many different types of labs. During next year we will continue to expand our molecular test offering for critical blood stream and perinatal infections."

About the GenomEra CDX™ System Molecular Diagnostic Platform

The GenomEra CDX system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GenomEra CDX system is designed for clinical routine use for identification of target nucleic acid sequences directly from crude clinical samples and delivering reliable non-confusing answers in less than in one hour. The GenomEra CDX system combines minimal sample preparation with rapid and high-performing PCR (polymerase chain reaction) amplification and end-point detection for fully integrated and automated nucleic acid analysis. GenomEra CDX system is the first commercial homogenous PCR platform to use thermally stable, intrinsically fluorescent time-resolved fluorometric (TRF) labels combined with a proprietary assay and measurement technology with effective elimination of background effects originating from e.g. crude clinical samples.

About Abacus Diagnostica

Abacus Diagnostica Oy is a Finnish ISO9001:2008 and ISO13485:2003 certified IVD company specialized in rapid DNA testing. Our proprietary, fully automated GenomEra CDX™-platform makes it possible to perform high-performance DNA-based testing even outside a specialized laboratory and by personnel without experience in molecular biology.

The company's business focus is in Healthcare Associated Infections, Bloodstream Infections and Perinatal Diagnostics. The Abacus GenomEra CDX system is currently available in Europe with CE-IVD mark. Applications include a test panel for MRSA/SA for various matrixes including blood culture for sepsis care, and the Clostridium difficile test for stool samples. Next tests in pipeline are Streptococcus pneumoniae and Streptococcus agalactiae (GBS).

http://www.abacusdiagnostica.com


'/>"/>
SOURCE Abacus Diagnostica Ltd
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
2. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
3. Nephros Receives 510(k) Clearance for Hemodiafiltration System
4. ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
5. BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award
6. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
7. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
8. Alexza Receives Complete Response Letter for Adasuve™ NDA
9. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
10. Marshall Edwards Receives $4 Million Subscription From Novogen In Rights Offering
11. New Chronic Wound Treatment Device Receives Award from Veterans Healthcare Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2017)... 2017  Researchers from DRUGSCAN ® and INC ... a live, complimentary webinar titled, "Untangling methods to tamper ... real world" on Wednesday June 28, 2017 from 12:00 ... webinar will feature interviews with recreational and dependent prescription ... techniques abusers use to prepare opioid tablets for routes ...
(Date:6/14/2017)... 14, 2017  ivWatch LLC, a medical device company ... (IV) therapy, is pleased to announce it was the ... Hospital Supplies and Equipment at the 2017 Medical Design ... medtech industry. The award was presented by Medical Device ... Center in New York during ...
(Date:6/13/2017)... , June 13, 2017 Zimmer Biomet Holdings, Inc. ... today announced that the U.S. Food and Drug Administration (FDA) ... 3, 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning Letter ... manufacturing facility is a measure of the progress we have ...
Breaking Medicine Technology:
(Date:6/20/2017)... ... June 20, 2017 , ... After months of negotiations, FaceCradle USA is proud to ... on Wednesday, June 21. , “Introducing our product on QVC is something we all worked ... our travel pillow to more than 90 million homes in the United States,” said FaceCradle ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... the introduction of school choice can promote economic development in economically distressed urban ... has, according to the report, contributed to the economic development of the city ...
(Date:6/20/2017)... ... 2017 , ... Dr. Manju R. Kejriwal currently accepts new ... or not they have a referral. Dr. Kejriwal offers state-of-the-art treatment through the ... bacteria and damaged tissue without affecting the surrounding tissue. This technology virtually eliminates ...
(Date:6/20/2017)... ... 20, 2017 , ... Many RNA binding proteins (RBPs) regulate ... team developed expressRNA, a web platform encompassing computational tools for integration of the ... the ‘RNA maps’, which demonstrate that RBPs bind to specific positions on pre-mRNAs ...
(Date:6/20/2017)... ... June 20, 2017 , ... John D'Eri, CEO of Rising Tide ... Adult Autism Award during the Autism Society of America 's 49th annual ... Daniel Jordan Fiddle Foundation (DJFF) was founded in 2002 as the nation's first ...
Breaking Medicine News(10 mins):